Manchester Lung Health Study

NCT ID: NCT04409444

Last Updated: 2023-05-31

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 9730 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-08-20
• Study Completion Date: 2024-08-31

Brief Summary

The Manchester Lung Health Study (qUEST) will assess the uptake of a community-based lung cancer screening service and its impact across a deprived area of North and East Manchester, which has high rates of lung cancer. One measure will be to compare the number and stage of lung cancers detected through screening to those detected outside of screening. In addition we will investigate the potential of a blood and nose test to detect lung cancer or to help decide who would benefit from screening. We will also see if these samples can help with the interpretation of CT scans. One of the problems with lung cancer CT screening is that you detect lung nodules in which we are not sure if they are benign or cancerous. Therefore we are also looking to see if a biomarker can help us work out which are cancerous and which are benign.

Conditions

Lung Cancer

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Data (main study)

This study group is for any individual that attends and has a lung health check. The data collected for this study group is to evaluate the uptake and performance of a community-based lung health check / lung screening programme.

Lung Cancer Screening

Intervention Type: DIAGNOSTIC_TEST

The lung health check consists of a symptom questionnaire for the calculation of 6-year lung cancer risk (using the PLCOM2012 model)

Biomarker (sub-study)

This sub-study is for participants that are determined to require a CT scan through their lung health check and have also signed up to the data part of the study. This part of the study is to evaluate the potential for biomarkers to improve the early detection of lung cancer.

Lung Cancer Screening

Intervention Type: DIAGNOSTIC_TEST

The lung health check consists of a symptom questionnaire for the calculation of 6-year lung cancer risk (using the PLCOM2012 model)

Biomarkers

Intervention Type: DIAGNOSTIC_TEST

This will explore the role of biomarkers for the early detection of lung cancer. These include circulating nucleic acids, circulating proteins, circulating tumour cells and inflammatory markers.

Interventions

Lung Cancer Screening

The lung health check consists of a symptom questionnaire for the calculation of 6-year lung cancer risk (using the PLCOM2012 model)

Intervention Type: DIAGNOSTIC_TEST

Biomarkers

This will explore the role of biomarkers for the early detection of lung cancer. These include circulating nucleic acids, circulating proteins, circulating tumour cells and inflammatory markers.

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

Inclusion Criteria

• Age 55-80
• Ever smoker
• Registered with a GP in the North or East Manchester area

• Any individual attending the M-LHC service who is eligible and agrees to undergo LDCT screening.
• Has consented to the main study.

Exclusion Criteria

• Lung cancer diagnosis within 5 years
• Listed on a palliative care register
• Chest CT scan within 3 months

• Unable to give informed consent to study participation.

Biomarker sub-study:

• Unable to give informed consent to study participation
• Decline participation in LDCT lung cancer screening
• Known blood borne virus e.g. HIV or Hepatitis B, C

• Minimum Eligible Age: 55 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cancer Research UK

OTHER

Sponsor Role: collaborator

University of Manchester

OTHER

Sponsor Role: collaborator

Manchester University NHS Foundation Trust

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Philip Crosbie

Role: PRINCIPAL_INVESTIGATOR

Manchester University NHS Trust

Locations

Manchester University NHS Trust

Manchester, , United Kingdom

Site Status: RECRUITING

Countries

United Kingdom

Central Contacts

Philip Crosbie

Role: CONTACT

philip.crosbie@manchester.ac.uk

01612912116

Sara Waplington

Role: CONTACT

sara.waplington@mft.nhs.uk

01612912835

Facility Contacts

Philip Crosbie

Role: primary

philip.crosbie@manchester.ac.uk

01612912116

Sara Waplington

Role: backup

sara.waplington@mft.nhs.uk

01612912835

Other Identifiers

252263 (IRAS)

Identifier Type: OTHER

Identifier Source: secondary_id

19/LO/0404 (REC)

Identifier Type: OTHER

Identifier Source: secondary_id

B00212

Identifier Type: -

Identifier Source: org_study_id